- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02131454
Efficacy of Inhalation Technique Training.
Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Both asthma and COPD are common medical problems. Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The inhalation technique is the key factor for effective management of bronchial obstruction. At the same time, a significant proportion of patients with asthma or COPD do not use inhalers properly.
The aim of the study is:
- to analyze the frequency and type of common mistakes in inhalation technique and
- to determine the impact of short individual training of inhalation technique on the course of asthma and COPD.
Fifty patients with asthma and 50 patients with COPD treated in the out-patient clinic or in the Department of Internal Medicine, Pneumonology and Allergology will be enrolled to the study.
The stage of severity (COPD) and control of the disease (asthma), quality of life, proper inhaler intake will be assessed at the study onset and at a second visit after 6 months.
At the second visit all patients will get a short, individual information about the etiology, course and general treatment plan of asthma / COPD. Patients will be randomized into two groups:
A. group of patients trained in proper inhalation technique B. group of patients without inhalation technique training Control visits will be held 3 and 6 months after training.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Warsaw, Poland, 02-097
- Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- age of 18 - 80 years
- asthma or COPD diagnosed at least 6 months before study enrollment
- everyday usage of at least one of the following: pressured meter dose inhaler (pMDI) or dry powdered inhaler (Aerolizer, Handihaler, Disc or Turbuhaler)
- no other comorbidities that could influence learning of inhalation technique (psychiatric or neurologic disorders)
Exclusion criteria:
- age less than 18 or above 80 years
- lack of informed consent
- asthma or COPD diagnosed less than 6 months prior to screening visit
- coexistence of respiratory diseases other than asthma or COPD
- irregular use (not every day) of at least one inhaled drug
- treatment with inhalers other than: pMDI, Disc, Turbuhaler, Handihaler or Aerolizer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education and Inhalation technique training
Training in technique of drug inhalation in asthma and COPD patients and education about the role of inhalation therapy in the course of the disease.
|
Training in inhalation technique in asthmatics and COPD patients
|
No Intervention: Education
Basic education about asthma and COPD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma or COPD exacerbations
Time Frame: 6 months
|
The number and severity of asthma and COPD exacerbations.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life.
Time Frame: baseline, 3 months, 6 months
|
Change from baseline in quality of life questionnaires: for asthma patients - Asthma Quality of Life Questionnaire for COPD patients - Saint George's Respiratory Questionnaire |
baseline, 3 months, 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control.
Time Frame: baseline , 3 months , 6 months
|
Change from baseline in Asthma Control Test (ACT) or COPD Assessment Test (CAT)
|
baseline , 3 months , 6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2. Erratum In: Respir Med. 2012 May;106(5):757. DelDonno, Mario [corrected to Del Donno, Mario].
- Press VG, Arora VM, Shah LM, Lewis SL, Charbeneau J, Naureckas ET, Krishnan JA. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med. 2012 Oct;27(10):1317-25. doi: 10.1007/s11606-012-2090-9. Epub 2012 May 17.
- Al-Showair RA, Tarsin WY, Assi KH, Pearson SB, Chrystyn H. Can all patients with COPD use the correct inhalation flow with all inhalers and does training help? Respir Med. 2007 Nov;101(11):2395-401. doi: 10.1016/j.rmed.2007.06.008. Epub 2007 Jul 12.
- Dabrowska M, Luczak-Wozniak K, Miszczuk M, Domagala I, Lubanski W, Leszczynski A, Maskey-Warzechowska M, Rubinsztajn R, Hermanowicz-Salamon J, Krenke R. Impact of a Single Session of Inhalation Technique Training on Inhalation Skills and the Course of Asthma and COPD. Respir Care. 2019 Oct;64(10):1250-1260. doi: 10.4187/respcare.06740. Epub 2019 Jun 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WUM-TI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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